Associate Scientist/scientist

1 month ago

Exton, United States Frontage Lab Full time

Associate Scientist/Scientist - Biologics Service FTE team

Full Time

Exton PA or Client's site at Spring House PA

Frontage Laboratories

Frontage Laboratories is a CRO / Clinical Research Organization providing integrated, science-driven, product development services throughout the drug discovery and development process to enable life science companies to achieve their drug development goals. We have enabled many innovator, generic and consumer health companies of all sizes to file IND, NDA, ANDA, BLA and 505(b)(2) submissions in global markets allowing for successful development of important therapies and products for patients. We are committed to providing rigorous scientific expertise to ensure the highest quality and compliance. We have successfully assisted clients to advance hundreds of molecules through development to commercial launch in global markets. Come and join us to make a world of difference.

Biologics

Frontage's biologics teams have an average 10 - 15 years in complex drug development and have worked with large molecule applications throughout its evolution in product development. We can handle projects for a range of large molecule development projects including peptides, proteins, monoclonal antibodies, bispecific antibodies, biosimilars, oligonucleotides, biomarkers, and antibody drug conjugates.

Gain access to comprehensive biologics services in support of advanced development programs with Frontage's bioanalytical laboratory. We have the capabilities to analyze virtually any peptide, protein or antibody, and have built a reputation for solving technical challenges related to assay development and validation.

Position Summary:

This is a technical scientific position within the Biologics Service Team. The Biologics Service Team is responsible for conducting bioanalytical methods related to large molecule biotherapeutic drug development across all therapeutic areas, spanning nonclinical studies to post-market clinical development.

Responsibilities:

* Performs job duties with some supervision, with majority of interaction with direct supervisor and project team members.
* Collaborates effectively with fellow project members following priorities, checkpoints and timelines in support of objectives set by direct supervisor.
* Explains work with independent analysis and conclusions related to assigned tasks through written and oral communication.
* Executes the proper operation and maintenance of bioanalytical assays and laboratory procedures.
* Is a producer of top-level methods and robust experimental data.
* Identifies discrepancies in experimental data and assists with troubleshooting assay performance problems.
* Is up-to-date with the latest methods/techniques pertaining to functional area.
* Has a keen eye on functional process and compliance, and takes responsibility for successful execution of bioanalytical activities and compliance.
* Is savvy in the use of data management tools to record and retrieve data.
* Sets day-to day objectives and performs complex tasks and novel procedures.
* Communicates results to supervisor in a timely manner.
* Directly participates in the delivery of broader research efforts by acting as a flexible resource, supporting other functional areas and providing scientific input (e.g. assist Assay Development, Validation and troubleshooting, Assay Transfers).

CORE RESPONSIBILITIES:

* May conduct the following:
* Independently set up bioanalytical runs
* Prepare samples manually or via Hamilton Liquid Automation
* Perform assay steps manually or via Hamilton Liquid Automation
* Track samples and reagents appropriately in Watson Laboratory Information Management System (LIMS) or Mosaic reagent management system
* Confirm physical and virtual inventory in Watson LIMS for sample return
* Critically review and interpret bioanalytical data (including the review of ELN experiments for peers and junior analysts)
* May create and place substances in Mosaic
* Perform bioanalysis on an as needed basis


* Maintain accurate record keeping and experimental data with the use of data analysis packages and standard databases
* Maintain real-time documentation in all applicable systems (Symyx ELN, Mosaic, Watson LIMS, OpenLab)
* Contribute bioanalytical expertise to the development of relevant systems or suggest improvements to these systems
* Author deviation memos or notes-to-file
* May write, review, and execute validation documents for Softmax Pro and/or Excel
* May create and review Symyx ELN templates
* May author/co-author technical reports (SOPs, BQSs, ISR/Para Vals)
* Critically review SOPs, BQS reports, technical reports and Validation/Qualification plans
* Maintain Good Laboratory Practice (GLP) compliance for all work and documentation

Requirements:

Education: M.S. with 1-5 years of relevant experience for Scientist or a B.S./B.A. with 1-5 years of experience for Associate Scientist, performing progressively advanced duties at the Associate Scientist I level, or the equivalent training/experience.

Experience/Special Skills: Experience working in an analytical, biologics, or bioanalytical laboratory. Working knowledge of GLPs and other regulatory and safety standards is preferred. Experience with MesoScale Discovery, Hamilton Liquid Automation platforms is a plus. Experience with the Watson Laboratory Information System and an electronic notebook is a plus.

Significant Safety or Working Considerations:

May work with potentially infectious samples of human and/or animal origin May handle hazardous chemicals

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability

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